insomnia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age 18–75 years;2.Meeting the diagnostic criteria for insomnia disorder as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), published by the American Psychiatric Association (APA);3.Meeting the diagnostic criteria for insomnia of the heart-kidney disharmony pattern (xin-shen bu jiao type) as defined in Internal Medicine of Traditional Chinese Medicine;4.Mild to severe insomnia, defined as an Insomnia Severity Index (ISI) score of 8 to 21;5.No hearing impairment, and able to independently use a playback device to listen to five-element music files;6.No participation in other clinical trials within the past one month.
Exclusion criteria
Exclusion criteria: 1.Other sleep disorders (e.g., obstructive sleep apnea, parasomnia, narcolepsy);2.Shift work affecting circadian rhythm;3.Clinically unstable severe medical, surgical, or psychiatric conditions;4.Presence of skin infection or lesions on the umbilical region, back, or soles of the feet;5.Known allergy to the study medication or adhesive tape;6.Pregnant or breastfeeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index; | — |
Countries
China
Contacts
Hospital of Chengdu University of Traditional Chinese Medicine